MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH SOMATOM DRIVE; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number 10431700

Device Problem Misassembly During Maintenance/Repair (4054)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 05/18/2023

Event Type  Injury  

Manufacturer Narrative

Siemens is conducting a thorough investigation of the reported events.As this event is under investigation, a root cause has not yet been determined.A supplement report will be filed upon completion of the investigation.

Event Description

On (b)(6) 2023, it was reported to siemens that an adverse event occurred while servicing the somatom drive ct system.While performing maintenance activities, a service engineer opened the gantry ring top front cover to work inside the gantry.The cover did not hold in the open position and as a result, the service engineer was injured.The engineer suffered a minor injury in which a wound needed to be cleaned and bandaged.No critical injury was reported, and we are unaware of any further impact to the state of health of the engineer involved.The investigation has been started.The necessary parts were requested from australia.A supplemental report will be filed upon its completion.This report is filed with an abundance of caution.

• Brand Name: SOMATOM DRIVE
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemensstrasse 1; ~or~ rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; siemensstrasse 1; ~or~ rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer Contact: meredith adams ; 40 liberty blvd., mc 65-1a; malvern, PA 19355 ; 4843231631
• MDR Report Key: 17162377
• MDR Text Key: 317479827
• Report Number: 3004977335-2023-00045
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K230421
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 10431700
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 48 YR
• Patient Sex: Male